[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Rules and Regulations]
[Pages 14820-14822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05799]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP73


Release of VA Records Relating to HIV

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) is amending its 
medical regulations governing the release of VA medical records. 
Specifically, VA is eliminating the restriction on sharing a negative 
test result for the human immunodeficiency virus (HIV) with veterans' 
outside providers. HIV testing is a common practice today in healthcare 
and the stigma of testing that may have been seen in the 1980s when HIV 
was first discovered is no longer prevalent. Continuing to protect 
negative HIV tests causes delays and an unnecessary burden on veterans 
when VA tries to share electronic medical information with the 
veterans' outside providers through electronic health information 
exchanges. For this same reason, VA will also eliminate restrictions on 
negative test results of sickle cell anemia. This final rule eliminates 
the current barriers to electronic medical information exchange.

DATES: This final rule is effective April 24, 2017.

[[Page 14821]]


FOR FURTHER INFORMATION CONTACT: Stephania H. Griffin, Director, 
Information Access and Privacy Office (10P2C), Department of Veterans 
Affairs, 810 Vermont Avenue NW., Washington, DC 20420; (704) 245-2492. 
(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on August 5, 2016, VA proposed to revise its regulations that 
govern the release of VA medical records, specifically eliminating the 
restriction on protecting a negative test result for HIV and sickle 
cell anemia. 81 FR 51836. VA provided a 60-day comment period, which 
ended on October 4, 2016. We received 5 comments on the proposed rule.
    Section 7332 of 38 United States Code (U.S.C.) states that records 
of the identity, diagnosis, prognosis, or treatment of any patient or 
subject which are maintained in connection with the performance of any 
program or activity (including education, training, treatment, 
rehabilitation, or research) of any patient or subject relating to drug 
abuse, alcoholism or alcohol abuse, infection with the human 
immunodeficiency virus (HIV), or sickle cell anemia shall only be 
disclosed under certain circumstances. The intent of section 7332 is to 
protect the medical records of those veterans who are undergoing 
treatment or have a positive diagnosis for the conditions stated in 
this section. Due to the stigma that was associated with HIV and HIV 
testing at the time the regulation was first published, VA determined 
that the results of HIV testing should be protected regardless of the 
outcome of the test. Currently, HIV testing is considered part of 
routine health care under VA policy, similar to other types of 
diagnostic laboratory testing, and while oral informed consent is still 
required, no pre-testing counseling is required.
    The continued protection of negative HIV tests has posed 
significant obstacles to the sharing of medical information between VA 
and non-VA medical providers, and also places an undue burden on 
veterans. If VA conducts an HIV test on a veteran, VA is prevented from 
electronically disclosing the veteran's medical information to the 
veteran's non-VA medical provider, even if the test result is negative, 
unless VA first obtains a specific written authorization that meets 
title 38 regulatory requirements from the veteran to share the medical 
information. Medical information sharing is crucial to treating a 
veteran who has outside medical providers and is significant in making 
certain that a veteran is not prescribed a medication that may 
negatively interact with other medications. Under section 7332, 
information about sickle cell anemia is also considered protected 
medical information. As with negative HIV test results, the prohibition 
on sharing negative test results for sickle cell anemia has posed 
challenges for the timely provision of medical care. This rulemaking 
eliminates the current restrictions on sharing with community providers 
negative test results of veterans for HIV and sickle cell anemia and is 
in line with the intent of the statute. As for positive HIV or sickle 
cell anemia test results, VA will continue to require a qualifying 
written authorization from the veteran prior to disclosure of such 
information.
    We received five comments in support of the proposed rule. All 
commenters agreed that the electronic exchange of negative HIV and 
sickle cell anemia test results between medical providers is a critical 
to adequately address patient care. A commenter stated ``By removing 
the restriction on disclosure of negative test result for HIV, this 
proposed rule will play a significant role in ensuring that all 
veterans, including LGBT veterans, have access to efficient care, while 
also helping combat the stigma associated with HIV testing.'' We thank 
the commenters for their support of the rule.
    Based on the rationale set forth in the Supplementary Information 
to the proposed rule and in this final rule, VA is adopting the 
proposed rule with no edits.

Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this 
final rulemaking, represents VA's implementation of its legal authority 
on this subject. Other than future amendments to this regulation or 
governing statutes, no contrary guidance or procedures are authorized. 
All existing or subsequent VA guidance must be read to conform with 
this rulemaking if possible or, if not possible, such guidance is 
superseded by this rulemaking.

Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule will impose no burden on small entities. 
Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking would be exempt 
from the initial and final regulatory flexibility analysis requirements 
of 5 U.S.C. 603 and 604.

Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866. VA's impact analysis can be found as a 
supporting document at http://www.regulations.gov, usually within 48 
hours after the rulemaking document is published. Additionally, a copy 
of the rulemaking and its impact analysis are available on VA's Web 
site at http://www.va.gov/orpm/, by following the link for ``VA 
Regulations Published From FY 2004 Through Fiscal Year to Date.''

[[Page 14822]]

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This final rule will have no such effect on 
State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.007, Blind Rehabilitation 
Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans 
Dental Care; 64.012, Veterans Prescription Service; 64.014, Veterans 
State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 
64.018, Sharing Specialized Medical Resources; 64.019, Veterans 
Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based 
Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem 
Program.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on March 16, 2017, for publication.

List of Subjects in 38 CFR Part 1

    Administrative practice and procedure, Archives and records, 
Cemeteries, Claims, Courts, Crime, Flags, Freedom of information, 
Government contracts, Government employees, Government property, 
Infants and children, Inventions and patents, Parking, Penalties, 
Privacy, Reporting and recordkeeping requirements, Seals and insignia, 
Security measures, Wages.

    For the reasons set out in the preamble, Department of Veterans 
Affairs is amending 38 CFR part 1 as follows:

PART 1--GENERAL PROVISIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  38 U.S.C. 501(a), and as noted in specific sections.

0
2. Amend Sec.  1.460 by revising the last sentence of the definition of 
``Infection with the human immunodeficiency virus (HIV)'' and the 
definitions of ``Patient'' and ``Treatment'' to read as follows:


Sec.  1.460   Definitions

* * * * *
    Infection with the human immunodeficiency virus (HIV). * * * The 
term does not include negative results from the testing of an 
individual for the presence of the virus or antibodies to the virus, or 
such testing of an individual where the results are negative.
* * * * *
    Patient. The term ``patient'' means any individual or subject who 
has been given a diagnosis or treatment for drug abuse, alcoholism or 
alcohol abuse, infection with the human immunodeficiency virus, or 
sickle cell anemia and includes any individual who, after arrest on a 
criminal charge, is interviewed and/or tested in connection with drug 
abuse, alcoholism or alcohol abuse, infection with the human 
immunodeficiency virus, or sickle cell anemia in order to determine 
that individual's eligibility to participate in a treatment or 
rehabilitation program if the result of such testing is positive. The 
term ``patient'' includes an individual who has been diagnosed or 
treated for alcoholism, drug abuse, HIV infection, or sickle cell 
anemia for purposes of participation in a VA program or activity 
relating to those four conditions, including a program or activity 
consisting of treatment, rehabilitation, education, training, 
evaluation, or research. For the purpose of infection with the human 
immunodeficiency virus or sickle cell anemia, the term ``patient'' 
includes one tested positive for the disease even if no treatment is 
provided, offered, or requested. The term does not include a patient 
who has tested negative for the disease.
* * * * *
    Treatment. The term ``treatment'' means the management and care of 
a patient for drug abuse, alcoholism or alcohol abuse, or the 
diagnosis, management and care of a patient for infection with the 
human immunodeficiency virus, or sickle cell anemia, or a condition 
which is identified as having been caused by one or more of these 
conditions, in order to reduce or eliminate the adverse effects upon 
the patient. The term does not include negative test results for the 
human immunodeficiency virus, antibodies to the virus, or sickle cell 
anemia, or such testing of an individual where the results are 
negative.
* * * * *

0
3. Revising Sec.  1.461(a)(1)(i) to read as follows.


Sec.  1.461   Applicability.

    (a) * * *
    (1) * * *
    (i) Would identify a patient as an alcohol or drug abuser, an 
individual who tested positive for or is infected with the human 
immunodeficiency virus (HIV), hereafter referred to as HIV, or an 
individual who tested positive for or has sickle cell anemia, either 
directly, by reference to other publicly available information, or 
through verification of such an identification by another person; and
* * * * *

    Dated: March 16, 2017.
Jeffrey Martin,
Office Program Manager, Office of Regulation Policy & Management, 
Office of the Secretary, Department of Veterans Affairs.
[FR Doc. 2017-05799 Filed 3-22-17; 8:45 am]
 BILLING CODE 8320-01-P